NCT00941850已完成4 期
TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
University Hospitals, Leicester2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months
研究概览
简要总结
Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with a CRT device > 6 months previously according to current and conventional CRT indications
- •Device optimization > 1 months previously
- •Aged 18yrs or older
- •Able to attend outpatient follow up
排除标准
- •Recent MI (<2 months)
- •Women who are pregnant or planning pregnancy
- •Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
- •Upgrade procedure is contraindicated for safety reasons.
- •Class IV inotropic agents
- •Patient unwilling to comply with required follow-up protocol including randomization scheme
结局指标
主要结局
Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months
时间窗: 6 months
次要结局
- NYHA class(3 and 6 months)
- ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)(3 and 6 months)
- MVO2 max(6 months)
研究者
研究点 (2)
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